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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077989
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/06/2007 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077989s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077989s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2017 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/25/2017 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

06/02/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

06/02/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/02/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

06/02/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/25/2013 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/06/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077989s000lbl.pdf

FOSPHENYTOIN SODIUM

INJECTABLE;INJECTION; EQ 50MG PHENYTOIN NA/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEREBYX FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription Yes AP 020450 PARKE DAVIS
FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription No AP 078137 ATLANTIDE
FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription No AP 078052 FRESENIUS KABI USA
FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription No AP 077481 HIKMA
FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription No AP 077989 HIKMA
FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription No AP 078765 HIKMA FARMACEUTICA
FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription No AP 078736 MYLAN LABS LTD
FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription No AP 078417 SUN PHARM
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